Internal Medicine Commons^™

Clinical And Demographic Factors Associated With Covid-19, Severe Covid-19, And Sars-Cov-2 Infection In Adults: A Secondary Cross-Protocol Analysis Of 4 Randomized Clinical Trials, Deborah A Theodore, Angela R Branche, Lily Zhang, Daniel S Graciaa, Madhu Choudhary, Timothy J Hatlen, Raadhiya Osman, Tara M Babu, Samuel T Robinson, Peter B Gilbert, Dean Follmann, Holly Janes, James G Kublin, Lindsey R Baden, Paul Goepfert, Glenda E Gray, Beatriz Grinsztejn, Karen L Kotloff, Cynthia L Gay, Brett Leav, Jacqueline Miller, Ian Hirsch, Jerald Sadoff, Lisa M Dunkle, Kathleen M Neuzil, Lawrence Corey, Ann R Falsey, Hana M El Sahly, Magdalena E Sobieszczyk, Yunda Huang

Faculty, Staff and Student Publications

IMPORTANCE: Current data identifying COVID-19 risk factors lack standardized outcomes and insufficiently control for confounders.

OBJECTIVE: To identify risk factors associated with COVID-19, severe COVID-19, and SARS-CoV-2 infection.

DESIGN, SETTING, AND PARTICIPANTS: This secondary cross-protocol analysis included 4 multicenter, international, randomized, blinded, placebo-controlled, COVID-19 vaccine efficacy trials with harmonized protocols established by the COVID-19 Prevention Network. Individual-level data from participants randomized to receive placebo within each trial were combined and analyzed. Enrollment began July 2020 and the last data cutoff was in July 2021. Participants included adults in stable health, at risk for SARS-CoV-2, and assigned to the placebo group …

Allogeneic, Off-The-Shelf, Sars-Cov-2-Specific T Cells (Alvr109) For The Treatment Of Covid-19 In High-Risk Patients, Spyridoula Vasileiou, Laquisa Hill, Manik Kuvalekar, Aster G Workineh, Ayumi Watanabe, Yovana Velazquez, Suhasini Lulla, Kimberly Mooney, Natalia Lapteva, Bambi J Grilley, Helen E Heslop, Cliona M Rooney, Malcolm K Brenner, Todd N Eagar, George Carrum, Kevin A Grimes, Ann M Leen, Premal Lulla

Faculty, Staff and Students Publications

Defects in T-cell immunity to SARS-CoV-2 have been linked to an increased risk of severe COVID-19 (even after vaccination), persistent viral shedding and the emergence of more virulent viral variants. To address this T-cell deficit, we sought to prepare and cryopreserve banks of virus-specific T cells, which would be available as a partially HLA-matched, off-the-shelf product for immediate therapeutic use. By interrogating the peripheral blood of healthy convalescent donors, we identified immunodominant and protective T-cell target antigens, and generated and characterized polyclonal virus-specific T-cell lines with activity against multiple clinically important SARS-CoV-2 variants (including 'delta' and 'omicron'). The feasibility of …

Prognostic Value Of Severe Acute Respiratory Syndrome Coronavirus-2 Viral Load And Antibodies In Patients Hospitalized With Covid-19, Rebecca N Bauer, Anastasia Teterina, Haridha Shivram, Jacqueline Mcbride, Carrie M Rosenberger, Fang Cai, Min Bao, Larry Tsai, Oliver Gordon, Ivan T Lee, Jeffrey J Wallin, Danielle Porter, Kavita Juneja, Gregory Camus, Ivan O Rosas, Steffen Wildum

Faculty, Staff and Students Publications

Observational studies have identified the potential prognostic value for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) viral load and anti-SARS-CoV-2 antibodies in coronavirus disease 2019 (COVID-19). However, viral load in nasopharyngeal (NP) swabs produced inconsistent results in prognostic analyses, and the prognostic value of viral load or antibodies has not been confirmed in large clinical trials. COVACTA and REMDACTA were double-blind, randomized, controlled trials with a combined enrollment of 1078 patients hospitalized with COVID-19 treated with tocilizumab or placebo in COVACTA or tocilizumab plus remdesivir or placebo plus remdesivir in REMDACTA. We assessed the potential prognostic value of NP and serum …

Validation Of A Predictive Model For Hospital-Acquired Acute Kidney Injury With Emergence Of Sars-Cov-2 Variants, Meredith C Mcadams, Pin Xu, Michael Li, L Parker Gregg, Sameh N Saleh, Mauricio Ostrosky-Frid, Duwayne L Willett, Ferdinand Velasco, Christoph U Lehmann, S Susan Hedayati

Faculty, Staff and Students Publications

We previously developed and validated a model to predict acute kidney injury (AKI) in hospitalized coronavirus disease 2019 (COVID-19) patients and found that the variables with the highest importance included a history of chronic kidney disease and markers of inflammation. Here, we assessed model performance during periods when COVID-19 cases were attributable almost exclusively to individual variants. Electronic Health Record data were obtained from patients admitted to 19 hospitals. The outcome was hospital-acquired AKI. The model, previously built in an

Prevalence And Impact Of Gastrointestinal Manifestations In Covid-19 Patients: A Systematic Review, Bassam Hossain, Shoreh Qazi, Sumair Ahmad, Atif Saleem, Amanke Oranu, Fahad Malik

Journal of Community Hospital Internal Medicine Perspectives

Background and Objective: The aim of this study is to systematically analyze and summarize the implications of COVID-19 on the digestive system by quantitatively evaluating the prevalence of gastrointestinal symptoms such as nausea, vomiting, abdominal pain, constipation, diarrhea, anorexia. reported in COVID-19 cases. We simultaneously investigated other variables to determine the association of such symptoms in COVID-19 patients which can potentially influence the disease prognosis and outcome. This systematic review presents an updated literature on the issue as it requires more scientific discussion in order to better inform the medical community and authorities so that appropriate measures can be taken …

An Interesting Occurrence Of Bell’S Palsy With Atypical Presentation After Contracting Covid-19 Infection, Yen-Chung Wang, Yen-Hsiang Wang, Christian Sanchez

North Texas GME Research Forum 2023

Introduction: COVID-19 has been identified as primarily a respiratory illness, however, with its clinical manifestation of involvement with multiple organs, it is now considered a systemic illness. In particular, it also can elicit a broad spectrum of neurological symptoms. One of the proposed manifestations is Bell’s Palsy, an acute idiopathic facial nerve palsy that affects the lower motor neuron. Here we have a patient with recent COVID infection who presents with a unilateral facial droop along with unilateral weakness/tingling of extremities and was diagnosed with Bell’s Palsy.

Case Description: Patient is a 47-year-old male with a past medical history of …

Rapid Escape Of New Sars-Cov-2 Omicron Variants From Ba2-Directed Antibody Responses, Aiste Dijokaite-Guraliuc, Raksha Das, Daming Zhou, Helen M Ginn, Chang Liu, Helen M E Duyvesteyn, Jiandong Huo, Rungtiwa Nutalai, Piyada Supasa, Muneeswaran Selvaraj, Thushan I De Silva, Megan Plowright, Thomas A H Newman, Hailey Hornsby, Alexander J Mentzer, Donal Skelly, Thomas G Ritter, Nigel Temperton, Paul Klenerman, Eleanor Barnes, Susanna J Dunachie, Optic Consortium, Cornelius Roemer, Thomas P Peacock, Neil G Paterson, Mark A Williams, David R Hall, Elizabeth E Fry, Juthathip Mongkolsapaya, Jingshan Ren, David I Stuart, Gavin R Screaton

Faculty, Staff and Student Publications

In November 2021, Omicron BA.1, containing a raft of new spike mutations, emerged and quickly spread globally. Intense selection pressure to escape the antibody response produced by vaccines or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection then led to a rapid succession of Omicron sub-lineages with waves of BA.2 and then BA.4/5 infection. Recently, many variants have emerged such as BQ.1 and XBB, which carry up to 8 additional receptor-binding domain (RBD) amino acid substitutions compared with BA.2. We describe a panel of 25 potent monoclonal antibodies (mAbs) generated from vaccinees suffering BA.2 breakthrough infections. Epitope mapping shows potent …

Effect Of Thromboprophylaxis On Clinical Outcomes After Covid-19 Hospitalization, Tracy Y Wang, Abdus S Wahed, Alison Morris, Lisa Baumann Kreuziger, John G Quigley, Gervasio A Lamas, Alexandra J Weissman, Jose Lopez-Sendon, M Margaret Knudson, Deborah M Siegal, Raj S Kasthuri, Andrew J Alexander, Lana Wahid, Bassel Atassi, Peter J Miller, Janice W Lawson, Bela Patel, Jerry A Krishnan, Nancy L Shapiro, Deborah E Martin, Andrei L Kindzelski, Eric S Leifer, Jungnam Joo, Lingyun Lyu, Annie Pennella, Brendan M Everett, Mark W Geraci, Kevin J Anstrom, Thomas L Ortel, Activ-4c Study Group

Faculty, Staff and Student Publications

BACKGROUND: Patients hospitalized with COVID-19 have an increased incidence of thromboembolism. The role of extended thromboprophylaxis after hospital discharge is unclear.

OBJECTIVE: To determine whether anticoagulation is superior to placebo in reducing death and thromboembolic complications among patients discharged after COVID-19 hospitalization.

DESIGN: Prospective, randomized, double-blind, placebo-controlled clinical trial. (ClinicalTrials.gov: NCT04650087).

SETTING: Done during 2021 to 2022 among 127 U.S. hospitals.

PARTICIPANTS: Adults aged 18 years or older hospitalized with COVID-19 for 48 hours or more and ready for discharge, excluding those with a requirement for, or contraindication to, anticoagulation.

INTERVENTION: 2.5 mg of apixaban versus placebo twice daily for …

Association Of Glucose-6-Phosphate Dehydrogenase Deficiency With Outcomes In Us Veterans With Covid-19, Sarah H Elsea, Javad Razjouyan, Kyung Min Lee, Julie A Lynch, Sharyl Martini, Lavannya M Pandit

Faculty, Staff and Students Publications

IMPORTANCE: The underlying biological risk factors for severe outcome due to SAR-CoV-2 infection are not well defined.

OBJECTIVE: To determine the association between glucose-6-phosphate dehydrogenase (G6PD) deficiency and severity of COVID-19.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study included analysis of 24 700 veterans with G6PD enzyme testing prior to January 1, 2020, obtained through the US Veterans Health Administration national databases. These veterans were cross-referenced with the Veterans Administration COVID-19 Shared Data Resource for SARS-CoV-2 testing from February 15, 2020, to January 1, 2021. The final study population consisted of 4811 veterans who tested positive for SARS-CoV-2. Statistical …

Electrical Stimulation To Regain Lower Extremity Muscle Perfusion And Endurance In Patients With Post-Acute Sequelae Of Sars Cov-2: A Randomized Controlled Trial, Alejandro Zulbaran-Rojas, Myeounggon Lee, Rasha O Bara, Areli Flores-Camargo, Gil Spitz, M G Finco, Amir Behzad Bagheri, Dipaben Modi, Fidaa Shaib, Bijan Najafi

Faculty, Staff and Students Publications

Muscle deconditioning and impaired vascular function in the lower extremities (LE) are among the long‐term symptoms experienced by COVID‐19 patients with a history of severe illness. These symptoms are part of the post‐acute sequelae of Sars‐CoV‐2 (PASC) and currently lack evidence‐based treatment. To investigate the efficacy of lower extremity electrical stimulation (E‐Stim) in addressing PASC‐related muscle deconditioning, we conducted a double‐blinded randomized controlled trial. Eighteen (n = 18) patients with LE muscle deconditioning were randomly assigned to either the intervention (IG) or the control (CG) group, resulting in 36 LE being assessed. Both groups received daily 1 h E‐Stim …

Performance Of A Sars-Cov-2 Rt-Pcr Assay With Non-Traditional Specimen Types, Subathra Marimuthu, Holly Aliesky, Heather Ness, Daniya Sheikh, Sathya Rashmit, Dawn Balcom, Leslie A. Wolf

The University of Louisville Journal of Respiratory Infections

During the first two years of the coronavirus disease 2019 (COVID-19) pandemic, nasopharyngeal (NP) specimens were the gold standard for clinical diagnostic testing. As information about the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing the pandemic continued to be shared, it was clear that the virus could be detected in other specimen types during an active infection. The University of Louisville Infectious Diseases Laboratory accepted non-traditional specimen types, most without a paired, positive NP result, for research purposes only to support local epidemiology efforts. A real-time reverse transcription-polymerase chain reaction (RT-PCR) assay originally validated for NP specimens was used …

Inflammatory Biomarkers Differ Among Hospitalized Veterans Infected With Alpha, Delta, And Omicron Sars-Cov-2 Variants, Catherine Park, Shahriar Tavakoli-Tabasi, Amir Sharafkhaneh, Benjamin J Seligman, Bret Hicken, Christopher I Amos, Andrew Chou, Javad Razjouyan

Faculty, Staff and Students Publications

Mortality due to COVID-19 has been correlated with laboratory markers of inflammation, such as C-reactive protein (CRP). The lower mortality during Omicron variant infections could be explained by variant-specific immune responses or host factors, such as vaccination status. We hypothesized that infections due to Omicron variant cause less inflammation compared to Alpha and Delta, correlating with lower mortality. This was a retrospective cohort study of veterans hospitalized for COVID-19 at the Veterans Health Administration. We compared inflammatory markers among patients hospitalized during Omicron infection with those of Alpha and Delta. We reported the adjusted odds ratio (aOR) of the first …

Assessment Of Symptom, Disability, And Financial Trajectories In Patients Hospitalized For Covid-19 At 6 Months, Andrew J Admon, Theodore J Iwashyna, Lee A Kamphuis, Stephanie J Gundel, Sarina K Sahetya, Ithan D Peltan, Steven Y Chang, Jin H Han, Kelly C Vranas, Kirby P Mayer, Aluko A Hope, Sarah E Jolley, Ellen Caldwell, Max L Monahan, Katrina Hauschildt, Samuel M Brown, Neil R Aggarwal, B Taylor Thompson, Catherine L Hough

Faculty, Staff and Student Publications

IMPORTANCE: Individuals who survived COVID-19 often report persistent symptoms, disabilities, and financial consequences. However, national longitudinal estimates of symptom burden remain limited.

OBJECTIVE: To measure the incidence and changes over time in symptoms, disability, and financial status after COVID-19-related hospitalization.

DESIGN, SETTING, AND PARTICIPANTS: A national US multicenter prospective cohort study with 1-, 3-, and 6-month postdischarge visits was conducted at 44 sites participating in the National Heart, Lung, and Blood Institute Prevention and Early Treatment of Acute Lung Injury Network's Biology and Longitudinal Epidemiology: COVID-19 Observational (BLUE CORAL) study. Participants included hospitalized English- or Spanish-speaking adults without severe prehospitalization …

A Delicate Balance Between Antibody Evasion And Ace2 Affinity For Omicron Ba275, Jiandong Huo, Aiste Dijokaite-Guraliuc, Chang Liu, Daming Zhou, Helen M Ginn, Raksha Das, Piyada Supasa, Muneeswaran Selvaraj, Rungtiwa Nutalai, Aekkachai Tuekprakhon, Helen M E Duyvesteyn, Alexander J Mentzer, Donal Skelly, Thomas G Ritter, Ali Amini, Sagida Bibi, Sandra Adele, Sile Ann Johnson, Neil G Paterson, Mark A Williams, David R Hall, Megan Plowright, Thomas A H Newman, Hailey Hornsby, Thushan I De Silva, Nigel Temperton, Paul Klenerman, Eleanor Barnes, Susanna J Dunachie, Andrew J Pollard, Teresa Lambe, Philip Goulder, Optic Consortium, Isaric4c Consortium, Elizabeth E Fry, Juthathip Mongkolsapaya, Jingshan Ren, David I Stuart, Gavin R Screaton

Faculty, Staff and Student Publications

Variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have caused successive global waves of infection. These variants, with multiple mutations in the spike protein, are thought to facilitate escape from natural and vaccine-induced immunity and often increase in affinity for ACE2. The latest variant to cause concern is BA.2.75, identified in India where it is now the dominant strain, with evidence of wider dissemination. BA.2.75 is derived from BA.2 and contains four additional mutations in the receptor-binding domain (RBD). Here, we perform an antigenic and biophysical characterization of BA.2.75, revealing an interesting balance between humoral evasion and ACE2 receptor …

Sars-Cov-2 Vaccination-Associated Cutaneous Leukocytoclastic Vasculitis, Sesha Sai Kanakamedala, Feras Al-Moussally, Ramzy Daoud, Zafar Zeeshan

North Florida Division GME Research Day 2023

No abstract provided.

New Onset Hashimoto’S Thyroiditis Associated With Severe Rhabdomyolysis After Infection With Covid19, Nova Mebane, Jacqueline M. Phillips, Cynthia Salloum, Neva Mebane, Daniel Park

Gulf Coast Division GME Research Day 2023

No abstract provided.

Antithrombin Activity Is Associated With Persistent Thromboinflammation And Mortality In Patients With Severe Covid-19 Illness, Amber Chen-Goodspeed, Goutham Dronavalli, Xu Zhang, Jeanette M Podbielski, Bela Patel, Katalin Modis, Bryan A Cotton, Charles E Wade, Jessica C Cardenas

Faculty, Staff and Student Publications

Introduction: Severe COVID-19 illness can lead to thrombotic complications, organ failure, and death. Antithrombin (AT) regulates thromboinflammation and is a key component of chemical thromboprophylaxis. Our goal was to examine the link between AT activity and responsiveness to thromboprophylaxis, markers of hypercoagulability, and inflammation among severe COVID-19 patients.

Methods: This was a single-center, prospective observational study enrolling SARS-CoV-2-positive patients admitted to the intensive care unit on prophylactic enoxaparin. Blood was collected daily for 7 days to assess AT activity and anti-factor Xa levels. Patient demographics, outcomes, and hospital laboratory results were collected. Continuous variables were compared using Mann-Whitney tests, and …

Ethnic And Racial Differences In Self-Reported Symptoms, Health Status, Activity Level, And Missed Work At 3 And 6 Months Following Sars-Cov-2 Infection, Kelli N O'Laughlin, Robin E Klabbers, Imtiaz Ebna Mannan, Nicole L Gentile, Rachel E Geyer, Zihan Zheng, Huihui Yu, Shu-Xia Li, Kwun C G Chan, Erica S Spatz, Ralph C Wang, Michelle L'Hommedieu, Robert A Weinstein, Ian D Plumb, Michael Gottlieb, Ryan M Huebinger, Melissa Hagen, Joann G Elmore, Mandy J Hill, Morgan Kelly, Samuel Mcdonald, Kristin L Rising, Robert M Rodriguez, Arjun Venkatesh, Ahamed H Idris, Michelle Santangelo, Katherine Koo, Sharon Saydah, Graham Nichol, Kari A Stephens

Faculty, Staff and Student Publications

INTRODUCTION: Data on ethnic and racial differences in symptoms and health-related impacts following SARS-CoV-2 infection are limited. We aimed to estimate the ethnic and racial differences in symptoms and health-related impacts 3 and 6 months after the first SARS-CoV-2 infection.

METHODS: Participants included adults with SARS-CoV-2 infection enrolled in a prospective multicenter US study between 12/11/2020 and 7/4/2022 as the primary cohort of interest, as well as a SARS-CoV-2-negative cohort to account for non-SARS-CoV-2-infection impacts, who completed enrollment and 3-month surveys (

RESULTS: Following SARS-CoV-2 infection, the majority of symptoms were similar over time between ethnic and racial groups. At …

Prevalence Of Depressive Symptoms And Correlates Among Individuals Who Self-Reported Sars-Cov-2 Infection After Optimizing The Covid-19 Response In China, Liangjia Wei, Jiao Qin, Zhifeng Lin, Xinju Huang, Jinfeng He, Dee Yu, Fei Zhang, Sisi Li, Ping Cen, Mu Li, Tong Luo, Rongjing Zhang, Shanmei Zhong, Cai Qin, Zeyu Li, Yuan Yang, Huiqi Pan, Mengdi Zhao, Xiaoqiong Wu, Junjun Jiang, Hao Liang, Li Ye, Bingyu Liang

Faculty, Staff and Student Publications

BACKGROUND: The burden of depression symptoms has increased among individuals infected with SARS-CoV-2 during COVID-19 pandemic. However, the prevalence and associated factors of depressive symptoms among individuals infected with SARS-CoV-2 remain uncertain after optimizing the COVID-19 response in China.

METHODS: An online cross-sectional survey was conducted among the public from January 6 to 30, 2023, using a convenience sampling method. Sociodemographic and COVID-19 pandemic-related factors were collected. The depression symptoms were assessed using the Patient Health Questionnaire-9 (PHQ-9). Logistic regression analysis was performed to explore the associated factors with depressive symptoms.

RESULTS: A total of 2,726 participants completed the survey. …

Timing Of Invasive Mechanical Ventilation And Death In Critically Ill Adults With Covid-19: A Multicenter Cohort Study, Adam Green, Jean-Sebastien Rachoin, Christa Schorr, Phil Dellinger, Jonathan D Casey, Isabel Park, Shruti Gupta, Rebecca M Baron, Shahzad Shaefi, Krystal Hunter, David E Leaf

Faculty, Staff and Student Publications

PURPOSE: To investigate if the timing of initiation of invasive mechanical ventilation (IMV) for critically ill patients with COVID-19 is associated with mortality.

MATERIALS AND METHODS: The data for this study were derived from a multicenter cohort study of critically ill adults with COVID-19 admitted to ICUs at 68 hospitals across the US from March 1 to July 1, 2020. We examined the association between early (ICU days 1-2) versus late (ICU days 3-7) initiation of IMV and time-to-death. Patients were followed until the first of hospital discharge, death, or 90 days. We adjusted for confounding using a multivariable Cox …

Distinct Temporal Trajectories And Risk Factors For Post-Acute Sequelae Of Sars-Cov-2 Infection, Chen Chen, Sairam Parthasarathy, Jacqueline M Leung, Michelle J Wu, Katherine A Drake, Vanessa K Ridaura, Howard C Zisser, William A Conrad, Victor F Tapson, James N Moy, Christopher R Defilippi, Ivan O Rosas, Bellur S Prabhakar, Mujeeb Basit, Mirella Salvatore, Jerry A Krishnan, Charles C Kim

Faculty, Staff and Students Publications

BACKGROUND: The understanding of Post-acute sequelae of SARS-CoV-2 infection (PASC) can be improved by longitudinal assessment of symptoms encompassing the acute illness period. To gain insight into the various disease trajectories of PASC, we assessed symptom evolution and clinical factors associated with the development of PASC over 3 months, starting with the acute illness period.

METHODS: We conducted a prospective cohort study to identify parameters associated with PASC. We performed cluster and case control analyses of clinical data, including symptomatology collected over 3 months following infection.

RESULTS: We identified three phenotypic clusters associated with PASC that could be characterized as …

Liver Injury After Sars‐Cov‐2 Vaccination: Features Of Immune-Mediated Hepatitis, Role Of Corticosteroid Therapy And Outcome, Cumali Efe, Anand V Kulkarni, Benedetta Terziroli Beretta-Piccoli, Bianca Magro, Albert Stättermayer, Mustafa Cengiz, Daniel Clayton-Chubb, Craig Lammert, Christine Bernsmeier, Özlem Gül, Fatima Higuera-De La Tijera, Margarita Anders, Ellina Lytvyak, Mete Akın, Tugrul Purnak, Rodrigo Liberal, Mirta Peralta, Berat Ebik, Serkan Duman, Nurhan Demir, Yasemin Balaban, Álvaro Urzua, Fernando Contreras, Maria Grazia Venturelli, Yılmaz Bilgiç, Adriana Medina, Marcos Girala, Fulya Günşar, Maria-Carlota Londoño, Theodoros Androutsakos, Ayelen Kisch, Alper Yurci, Fatih Güzelbulut, Yasir Furkan Çağın, Enver Avcı, Murat Akyıldız, Emine Kübra Dindar-Demiray, Murat Harputluoğlu, Rahul Kumar, Sanjaya K Satapathy, Manuel Mendizabal, Marcelo Silva, Stefano Fagiuoli, Stuart K Roberts, Neşe Karadağ Soylu, Ramazan Idilman, Eric M Yoshida, Aldo J Montano-Loza, George N Dalekos, Ezequiel Ridruejo, Thomas D Schiano, Staffan Wahlin

Faculty, Staff and Student Publications

BACKGROUND AND AIMS: A few case reports of autoimmune hepatitis-like liver injury have been reported after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination. We evaluated clinical features, treatment response and outcomes of liver injury following SARS-CoV-2 vaccination in a large case series.

APPROACH AND RESULTS: We collected data from cases in 18 countries. The type of liver injury was assessed with the R-value. The study population was categorized according to features of immune-mediated hepatitis (positive autoantibodies and elevated immunoglobulin G levels) and corticosteroid therapy for the liver injury. We identified 87 patients (63%, female), median age 48 (range: 18-79) …

Bamlanivimab Use In A Military Treatment Facility, Eric Karr, Theodore Chung, Kathryn Burtson, Ronald J. Markert, Devin Kelly

Internal Medicine Faculty Publications

Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease 2019 (COVID-19), was first identified in 2019 in Wuhan, China, and has rapidly spread across the world. As of April 2021, SARS-CoV-2 has infected more than 140,000,000 and caused more than 3,000,000 deaths globally. In November 2020, the monoclonal antibody bamlanivimab was approved by the FDA for non-hospitalized patients with SARS-CoV-2 (COVID-19) who possessed risk factors for progression to severe COVID-19. This provided a treatment option that may help prevent hospitalization. Methods Patients who regularly received ambulatory care at a military treatment facility and who were …

Perceptions And Concerns Regarding Covid-19 Vaccination In A Military Base Population, Samuel R. Theis, Peter C. Li, Devin Kelly, Thad Ocampo, Andrew Berglund, Damien Morgan, Ronald J. Markert, Evan Fisher, Kathryn Burtson

Internal Medicine Faculty Publications

Introduction: Safe and effective vaccines against severe acute respiratory syndrome-associated coronavirus 2 are essential tools in the fight against the coronavirus disease 2019 (COVID-19) pandemic. However, hesitancy to vaccination is a major barrier to achieving herd immunity, particularly among a population working on a military base. To better understand the perceptions and concerns of these individuals, a voluntary survey was conducted. Materials and methods: An interactive, online survey was constructed and disseminated to individuals associated with Wright-Patterson Air Force Base (WPAFB) in Dayton, OH. Survey participation was voluntary with responses collected over the initial weeks in which WPAFB began to …

Association Of Mrna Vaccination With Clinical And Virologic Features Of Covid-19 Among Us Essential And Frontline Workers, The Heroes-Recover Network, Mark G Thompson, Sarang K Yoon, Allison L Naleway, Jennifer Meece, Thomas P Fabrizio, Alberto J Caban-Martinez, Jefferey L Burgess, Manjusha Gaglani, Lauren E W Olsho, Allen Bateman, Jessica Lundgren, Lauren Grant, Andrew L Phillips, Holly C Groom, Elisha Stefanski, Natasha Schaefer Solle, Katherine Ellingson, Karen Lutrick, Kayan Dunnigan, Meredith G Wesley, Kyley Guenther, Angela Hunt, Josephine Mak, Kurt T Hegmann, Jennifer L Kuntz, Adam Bissonnette, James Hollister, Spencer Rose, Tyler C Morrill, Karley Respet, Ashley L Fowlkes, Matthew S Thiese, Patrick Rivers, Meghan K Herring, Marilyn J Odean, Young M Yoo, Matthew Brunner, Edward J Bedrick, Deanna E Fleary, John T Jones, Jenna Praggastis, James Romine, Monica Dickerson, Sana M Khan, Julie Mayo Lamberte, Shawn Beitel, Richard J Webby, Harmony L Tyner

Faculty, Staff and Student Publications

IMPORTANCE: Data on the epidemiology of mild to moderately severe COVID-19 are needed to inform public health guidance.

OBJECTIVE: To evaluate associations between 2 or 3 doses of mRNA COVID-19 vaccine and attenuation of symptoms and viral RNA load across SARS-CoV-2 viral lineages.

DESIGN, SETTING, AND PARTICIPANTS: A prospective cohort study of essential and frontline workers in Arizona, Florida, Minnesota, Oregon, Texas, and Utah with COVID-19 infection confirmed by reverse transcriptase-polymerase chain reaction testing and lineage classified by whole genome sequencing of specimens self-collected weekly and at COVID-19 illness symptom onset. This analysis was conducted among 1199 participants with SARS-CoV-2 …

Respiratory Virus Surveillance Among Children With Acute Respiratory Illnesses - New Vaccine Surveillance Network, United States, 2016-2021, Ariana Perez, Joana Y Lively, Aaron Curns, Geoffrey A Weinberg, Natasha B Halasa, Mary Allen Staat, Peter G Szilagyi, Laura S Stewart, Monica M Mcneal, Benjamin Clopper, Yingtao Zhou, Brett L Whitaker, Elizabeth Lemasters, Elizabeth Harker, Janet A Englund, Eileen J Klein, Rangaraj Selvarangan, Christopher J Harrison, Julie A Boom, Leila C Sahni, Marian G Michaels, John V Williams, Gayle E Langley, Susan I Gerber, Angela Campbell, Aron J Hall, Brian Rha, Meredith Mcmorrow

Faculty, Staff and Student Publications

The New Vaccine Surveillance Network (NVSN) is a prospective, active, population-based surveillance platform that enrolls children with acute respiratory illnesses (ARIs) at seven pediatric medical centers. ARIs are caused by respiratory viruses including influenza virus, respiratory syncytial virus (RSV), human metapneumovirus (HMPV), human parainfluenza viruses (HPIVs), and most recently SARS-CoV-2 (the virus that causes COVID-19), which result in morbidity among infants and young children (1-6). NVSN estimates the incidence of pathogen-specific pediatric ARIs and collects clinical data (e.g., underlying medical conditions and vaccination status) to assess risk factors for severe disease and calculate influenza and COVID-19 vaccine effectiveness. Current NVSN …

The Association Of Baseline Plasma Sars-Cov-2 Nucleocapsid Antigen Level And Outcomes In Patients Hospitalized With Covid-19, Activ-3/Tico Study Group, Angela J Rogers, Deborah Wentworth, Andrew Phillips, Katy Shaw-Saliba, Robin L Dewar, Neil R Aggarwal, Abdel G Babiker, Weizhong Chang, Nila J Dharan, Victoria J Davey, Elizabeth S Higgs, Norman Gerry, Adit A Ginde, J W Awori Hayanga, Helene Highbarger, Jeroen L Highbarger, Mamta K Jain, Virginia Kan, Kami Kim, Perrine Lallemand, Bradley G Leshnower, Joseph K Lutaakome, Gail Matthews, Ahmad Mourad, Eleftherios Mylonakis, Ven Natarajan, Maria L Padilla, Lavannya M Pandit, Roger Paredes, Sarah Pett, Srikanth Ramachandruni, M Tauseef Rehman, Brad T Sherman, D Clark Files, Samuel M Brown, Michael A Matthay, B Taylor Thompson, James D Neaton, H Clifford Lane, Jens D Lundgren

Faculty, Staff and Students Publications

BACKGROUND: Levels of plasma SARS-CoV-2 nucleocapsid (N) antigen may be an important biomarker in patients with COVID-19 and enhance our understanding of the pathogenesis of COVID-19.

OBJECTIVE: To evaluate whether levels of plasma antigen can predict short-term clinical outcomes and identify clinical and viral factors associated with plasma antigen levels in hospitalized patients with SARS-CoV-2.

DESIGN: Cross-sectional study of baseline plasma antigen level from 2540 participants enrolled in the TICO (Therapeutics for Inpatients With COVID-19) platform trial from August 2020 to November 2021, with additional data on day 5 outcome and time to discharge.

SETTING: 114 centers in 10 countries. …

Threats Of Covid-19 Reinfection: A Review Of The Evidence From The Literature, Muhammad Luthfi Adnan, Ana Fauziyati

Jurnal Penyakit Dalam Indonesia

Case of COVID-19 reinfection are related to immune factors in patients who have recovered by the natural course of the infecting pathogen. However, the chance of COVID-19 reinfection are still not well established. This review aimed to discuss about reinfection-related studies, including causes and clinical manifestations, and reinfection management. Reinfection happens when a patient is infected by the SARS-CoV-2 virus, which has a different genome from previous infection. Although the comparison of clinical manifestation between reinfection and the previous infection is not clear, it is believed that vulnerable populations may have worse outcomes. Vaccination is the main option to reduce …

Efficacy And Safety Of Ensovibep For Adults Hospitalized With Covid-19 : A Randomized Controlled Trial, Christina Barkauskas, Eleftherios Mylonakis, Garyfallia Poulakou, Barnaby E Young, David M Vock, Lianne Siegel, Nicole Engen, Greg Grandits, Nilima R Mosaly, Andrew M Vekstein, Ralph Rogers, Fadi Shehadeh, Matthew Kaczynski, Evangelia K Mylona, Konstantinos N Syrigos, Vasiliki Rapti, David C Lye, Diong Shiau Hui, Lindsay Leither, Kirk U Knowlton, Mamta K Jain, Rubria Marines-Price, Alice Osuji, J Scott Overcash, Ioannis Kalomenidis, Zafeiria Barmparessou, Michael Waters, Karla Zepeda, Peter Chen, Sam Torbati, Francis Kiweewa, Nicholus Sebudde, Eyad Almasri, Alyssa Hughes, Sanjay R Bhagani, Alison Rodger, Uriel Sandkovsky, Robert L Gottlieb, Eriobu Nnakelu, Barbara Trautner, Vidya Menon, Joseph Lutaakome, Michael Matthay, Philip Robinson, Konstantinos Protopapas, Nikolaos Koulouris, Ivan Kimuli, Amiran Baduashvili, Dominique L Braun, Huldrych F Günthard, Srikanth Ramachandruni, Robert Kidega, Kami Kim, Timothy J Hatlen, Andrew N Phillips, Daniel D Murray, Tomas O Jensen, Maria L Padilla, Evan X Accardi, Katy Shaw-Saliba, Robin L Dewar, Marc Teitelbaum, Ven Natarajan, Sylvain Laverdure, Helene C Highbarger, M Tauseef Rehman, Susan Vogel, David Vallée, Page Crew, Negin Atri, Adam J Schechner, Sarah Pett, Fleur Hudson, Jonathan Badrock, Giota Touloumi, Samuel M Brown, Wesley H Self, Crystal M North, Adit A Ginde, Christina C Chang, Anthony Kelleher, Stephanie Nagy-Agren, Shikha Vasudeva, David Looney, Hien H Nguyen, Adriana Sánchez, Amy C Weintrob, Birgit Grund, Shweta Sharma, Cavan S Reilly, Roger Paredes, Agnieszka Bednarska, Norman P Gerry, Abdel G Babiker, Victoria J Davey, Annetine C Gelijns, Elizabeth S Higgs, Virginia Kan, Gail Matthews, B Taylor Thompson, Philippe Legenne, Richa Chandra, H Clifford Lane, James D Neaton, Jens D Lundgren

Faculty, Staff and Students Publications

BACKGROUND: Ensovibep (MP0420) is a designed ankyrin repeat protein, a novel class of engineered proteins, under investigation as a treatment of SARS-CoV-2 infection.

OBJECTIVE: To investigate if ensovibep, in addition to remdesivir and other standard care, improves clinical outcomes among patients hospitalized with COVID-19 compared with standard care alone.

DESIGN: Double-blind, randomized, placebo-controlled, clinical trial. (ClinicalTrials.gov: NCT04501978).

SETTING: Multinational, multicenter trial.

PARTICIPANTS: Adults hospitalized with COVID-19.

INTERVENTION: Intravenous ensovibep, 600 mg, or placebo.

MEASUREMENTS: Ensovibep was assessed for early futility on the basis of pulmonary ordinal scores at day 5. The primary outcome was time to sustained recovery through day …

Covid-19 And Lung Cavitation: A Clue To Pathogenesis?, Tanner W. Norris, Blake M. Snyder, Patryk Purta, Ryan P. Spilman, Vanessa J. Craig

HCA Healthcare Journal of Medicine

Lung cavitation as a complication of COVID-19 is rare. A 56-year-old male presented with lung cavitation, small volume hemoptysis, and violaceous discoloration of the right great toe, 5 weeks after diagnosis with COVID-19 pneumonia. The digital changes were consistent with previously described microvascular changes called "COVID toe." CT angiography of the chest was negative for pulmonary embolism but showed a 2.5 x 3.1 x 2.2 cm cavitation within the right lung. Extensive evaluation for commonly implicated infectious and autoimmune causes was negative. We concluded that the cavitary lung lesions were likely a complication of COVID-19 pneumonia and may implicate microangiopathy …